Baidu
map

药物临床试验 受试者损害处理•广东共识(2020年版)

2020-03-05 广东省药学会 广东省药学会

各医疗单位:

中文标题:

药物临床试验 受试者损害处理•广东共识(2020年版)

发布机构:

广东省药学会

发布日期:

2020-03-05

简要介绍:

各医疗单位:

为规范药物临床试验受试者损害处理行为,切实保护受试者安全和权益,促进新药临床试验良好发展,本会药物临床试验专业委员会编写了《药物临床试验 受试者损害处理•广东共识(2020年版)》,现予以发布,供各医疗单位参考。各单位在执行过程中遇到与本共识相关的任何问题,请及时向本会反映。

联系地址:广州市东风东路753号东塔7楼 广东省药学会  510080

联系电话:(020)37886326,37886321

传真:37886330

电子邮箱:gdsyxh45@126.com

网址:http://www.sinopharmacy.com.cn

 

相关资料下载:
[AttachmentFileName(sort=1, fileName=5e98120b54aa1.pdf)] GetToolGuiderByIdResponse(projectId=1, id=1cd5e1c0019a526a, title=药物临床试验 受试者损害处理•广东共识(2020年版), enTitle=, guiderFrom=广东省药学会, authorId=0, author=, summary=各医疗单位:, cover=, journalId=0, articlesId=null, associationId=1082, associationName=广东省药学会, associationIntro=广东省药学会前身为1945年成立的广州药师公会,1951年成为中国药学会广州分会。1958年在原有基础上扩大组织,成立中国药学会广东分会,负责组织全省药学科技工作者的相关活动。1985年起,中国药学会广东分会一直挂靠在广东省食品药品监督管理局(省医药管理局)。1991年,按民政部门文件要求更名为广东省药学会。, copyright=0, guiderPublishedTime=Thu Mar 05 00:00:00 CST 2020, originalUrl=, linkOutUrl=, content=<p>各医疗单位:</p> <p>为规范药物临床试验受试者损害处理行为,切实保护受试者安全和权益,促进新药临床试验良好发展,本会药物临床试验专业委员会编写了《药物临床试验 受试者损害处理&bull;广东共识(2020年版)》,现予以发布,供各医疗单位参考。各单位在执行过程中遇到与本共识相关的任何问题,请及时向本会反映。</p> <p>联系地址:广州市东风东路753号东塔7楼 广东省药学会&nbsp; 510080</p> <p>联系电话:(020)37886326,37886321</p> <p>传真:37886330</p> <p>电子邮箱:gdsyxh45@126.com</p> <p>网址:http://www.sinopharmacy.com.cn</p> <p>&nbsp;</p>, tagList=[TagDto(tagId=109, tagName=临床试验)], categoryList=[CategoryDto(categoryId=85, categoryName=指南&解读, tenant=100), CategoryDto(categoryId=21100, categoryName=达仁堂循证e学界, tenant=100)], articleKeywordId=0, articleKeyword=, articleKeywordNum=6, guiderKeywordId=0, guiderKeyword=, guiderKeywordNum=6, haveAttachments=1, attachmentList=null, guiderType=0, guiderArea=共识, guiderLanguage=0, guiderRegion=3, opened=0, paymentType=, paymentAmount=10, recommend=0, recommendEndTime=null, sticky=0, stickyEndTime=null, allHits=2195, appHits=40, showAppHits=0, pcHits=874, showPcHits=2155, likes=0, shares=5, comments=6, approvalStatus=1, publishedTime=Mon Aug 03 23:12:38 CST 2020, publishedTimeString=2020-03-05, pcVisible=1, appVisible=1, editorId=4754896, editor=fbzhang, waterMark=0, formatted=0, memberCards=[], isPrivilege=0, deleted=0, version=2, createdBy=null, createdName=fbzhang, createdTime=Mon Aug 03 23:12:33 CST 2020, updatedBy=4754896, updatedName=fbzhang, updatedTime=Sat Jan 06 22:44:46 CST 2024, courseDetails=[], otherVersionGuiders=[], isGuiderMember=false, ipAttribution=, attachmentFileNameList=[AttachmentFileName(sort=1, fileName=5e98120b54aa1.pdf)])
5e98120b54aa1.pdf
下载请点击:
评论区 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2021-07-25 孤云独闲两不厌

    如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2020-11-29 146636e7m23暂无昵称

    学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2020-08-06 飞翔的乌龟

    学习了,很棒的资料

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1002460, encodeId=dc8d100246026, content=如果试验中申办方或CRO公司没有给受试者买个人险,与试验药物可能不相关的AE如何赔偿,赔偿的具体细则呢?计划外来院随访是否包含误工费和交通费, beContent=null, objectType=guider, channel=null, level=null, likeNumber=105, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210727/5b39a481862646a8acdae190e97f9f10/eb762bdb479e4f81a483d1b51705abd1.jpg, createdBy=71f95549536, createdName=孤云独闲两不厌, createdTime=Sun Jul 25 10:40:38 CST 2021, time=2021-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=903196, encodeId=6d0490319683, content=学习了, beContent=null, objectType=guider, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ec1b5134851, createdName=146636e7m23暂无昵称, createdTime=Sun Nov 29 06:52:01 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806452, encodeId=0fd38064526c, content=学习了,很棒的资料, beContent=null, objectType=guider, channel=null, level=null, likeNumber=140, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201110/2d55d24dc5fd419d994b7b920c79731b/d3c8bdca983c4af1b90220a8192e353a.jpg, createdBy=e14e5296465, createdName=飞翔的乌龟, createdTime=Thu Aug 06 09:26:49 CST 2020, time=2020-08-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=806024, encodeId=4521806024dc, content=学习, beContent=null, objectType=guider, channel=null, level=null, likeNumber=126, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200804/62f3c5bb78aa4f1bac3aef7bcd9c1c0d/029c3f00f77d40db887fd7feb647c9ef.jpg, createdBy=c8e65408461, createdName=月瘦如眉, createdTime=Tue Aug 04 08:27:07 CST 2020, time=2020-08-04, status=1, ipAttribution=)]
    2020-08-04 月瘦如眉

    学习

    0

Baidu
map
Baidu
map
Baidu
map